Compendia Compliance Lead

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Purpose

Responsible for managing and implementing quality compliance programs and measures to ensure AbbVie medicines and ingredients are safe, effective, and of appropriate quality. Initiates and leads high impact, global, cross-functional projects as response to complex large scale external compliance standard updates and changes. Benchmarks and participates in industry interest organizations, representing AbbVie’s interests, and influences regulation modification and establishment when possible.

Responsibilities

• Owns external compliance standard updates, such as compendia changes, from identification of the change through assessment and implementation for assigned scope
• Manages the assessment and implementation of compliance related changes according to official timelines, acting as the event owner in the corporate Quality Management System
• Actively follows up with Subject Matter Experts (SMEs), such as QA and R&D site contacts, as well as Quality COE leads, to ensure the implementation of changes are completed in a timely manner, including initiating the Document Change Control (DCC) process and updating impacted documents
• Provides interpretation of compendia or other quality compliance standards to functional areas such as Regulatory, QA, R&D, Manufacturing
• Leads the generation of metrics to monitor the performance of compliance
• Leads complex cross-functional initiatives or projects to address or implement compliance
• Proactively represents AbbVie's interests with applicable external industry interest groups and organizations, such as the assigned compendia
• Serves as the AbbVie point of contact for external parties related to compliance and communicates to them any comments, questions, or issues from internal SMEs. Leads alignment activities between external and internal stakeholders

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area required
• 6+ years in quality assurance and/or quality system oversight required. 5+ years of experience with working and/or developing analytical methods in QC, S&T or R&D labs preferred
• Experienced in the use of standard software applications including Office 365
• Strong interpersonal, verbal, and written communication skills, effective facilitation and collaboration with stakeholders (including sites or cross-functional teams)
• High level of competence, confidence, and credibility for interaction with stakeholders
• Proficient organization, planning, and project management skills
• Ability to demonstrate high level of independence and decision making, anticipate program scope and deliverable changes, and effectively communicate issues with management
• Strong analytical skillsets, detailed and quality oriented, and with great judgment and integrity
• Ability to provide strategic direction and support for problem solving
• Must demonstrate effective performance to prevent legal or regulatory vulnerabilities which would result in product recall or governmental seizure for lack of compliance to requirements

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html